U.S. Regulatory Strategist

Overview

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.

We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

• Communicator
• Detail-oriented
• Problem-solver
• Relationship-builder
• Results-driven
• Strategic

About This Role

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart.

About the Role

We are seeking experienced U.S. Regulatory Strategists at the Senior Regulatory Affairs Associate and Regulatory Affairs Consultant levels to join our team in a remote capacity. As a U.S. Regulatory Strategist, you will support and execute U.S. regulatory strategies for vaccine and biologic programs across development, registration, and post-approval lifecycle activities. Your work helps bring new vaccines and biologic therapies to patients in the United States and advances clinical research. This position plays a key role in U.S. regulatory strategy, FDA interactions, regulatory submissions, and labeling and lifecycle compliance. You will collaborate with global regulatory and cross-functional teams, apply strong knowledge of FDA requirements, and contribute to regulatory decisions from planning through post-approval activities. Responsibilities include U.S. regulatory strategy development, FDA interactions, regulatory submissions, global regulatory collaboration, labeling and lifecycle management, regulatory intelligence, and cross-functional collaboration, with opportunities to deepen your expertise and influence regulatory outcomes.

You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic U.S. regulatory support, timely and compliant FDA submissions, and close partnership with global regulatory and cross-functional teams. With diverse teams and continuous learning opportunities, as a U.S. Regulatory Strategist you can explore different career paths and expand skills across regulatory affairs and clinical research.

Key Responsibilities

• Develop, support, and execute U.S. regulatory strategies that align with global development, registration, and lifecycle management plans.

• Support or lead FDA interactions, including meeting preparation, responses to agency questions, regulatory issue resolution, and management of commitments.

• Plan, coordinate, review, and support the execution of U.S. regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologics License Applications (BLAs), supplements to NDAs and BLAs (sNDAs and sBLAs), and post-approval submissions.

• Represent U.S. regulatory requirements and perspectives within global regulatory teams, contributing to regulatory strategy, submission planning, and decision-making.

• Support U.S. Prescribing Information, labeling updates, regulatory compliance, and post-approval activities.

• Monitor and interpret evolving FDA regulations, guidance documents, and policies, and assess their potential impact on assigned programs.

• Partner with Clinical, CMC (Chemistry, Manufacturing, and Controls), Safety, Medical, Commercial, and global Regulatory teams to ensure timely and compliant regulatory deliverables.

• Candidate Profile

You'll thrive in this role if you bring:

• Practical U.S. regulatory strategy experience and direct FDA exposure

• The ability to operate effectively within a global regulatory organization and contribute beyond submission coordination or regulatory operations

• Strengths in regulatory writing and review, organization, and problem-solving

• The ability to collaborate across teams and communicate clearly

• Required Qualifications

• Degree in life sciences, pharmacy, or a related scientific discipline

• Senior Regulatory Affairs Associate: approximately 5-8 years of relevant experience in Canadian Regulatory Affairs

• Regulatory Affairs Consultant: approximately 8+ years of relevant experience in Canadian Regulatory Affairs

• Strong working knowledge of FDA regulations, regulatory pathways, and submission requirements, including those of the Center for Biologics Evaluation and Research (CBER) for vaccines and biologics

• Hands-on experience with U.S. regulatory submissions, particularly New Drug Applications (NDAs), Biologics License Applications (BLAs), supplemental NDAs and BLAs (sNDAs and sBLAs), and post-approval activities

• Experience working with global regulatory teams and cross-functional stakeholders

• Strong communication, organization, problem-solving, and regulatory writing and review skills

• Preferred Qualifications

• Experience with vaccines, biologics, or other complex products

• Experience within the pharmaceutical, biotechnology, or vaccine industry

• Hands-on experience with Investigational New Drug (IND) applications

• Due to the client’s location, candidates located in the eastern and central time zone of the United States are strongly preferred.

• Benefits and Compensation

• Health, Vision & Dental Insurance

• Tuition Reimbursement

• Vacation/Holiday/Sick Time

• Flexible Spending & Health Savings Accounts

• Work/Life Balance

• 401(k) with Company match

• Pet Insurance

• For a complete list of benefits, please visit www.parexel.com/us-benefits.

• We offer competitive salaries based on several factors, including the position and level offered, skills, education, training, experience, professional achievements, and location.

• Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.

• If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!

• We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

• We are inspired by the patients behind the data and therefore deliver first-time quality and on-time projects.

• Supportive and inclusive environment

• We thrive on collaboration, caring, and inclusivity - enabling our people to work together to solve complex problems and share knowledge.

• Opportunities for career growth

• We provide a wide range of challenging assignments, product types, geographic regions, and therapeutic areas, providing ample opportunities for learning and growth.

• Flexible work arrangements

• We offer the flexibility of remote work, allowing you to balance your personal and professional responsibilities while still contributing to our “We Care” team environment.

• Diverse and global client exposure

• We continuously learn by working with a global network of colleagues and clients to develop regulatory strategies to support their product development